Roflumilast Versus Methotrexate in Psoriasis

Sponsor
Cairo University
Study ID
NCT05684744
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
  • Methotrexate — DRUG
    The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Study Details

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Key Dates

Start date
Jan 9, 2023
Status verified
May 2023
Primary completion
May 9, 2023
Completion
May 14, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    oral roflumilast in a dose of 500 mcg per day
  • Active Comparator: Methotrexate
    oral methotrexate in a dose of 0.2- 0.4 mg/kg/week

Primary Outcome Measure

Psoriasis Severity Index (PASI) before and after Roflumilast [ Time Frame: 12 weeks ]

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